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NCT03735797 Clinical Trial

Cancer Stem Cells in Acute Leukemia

Acute Leukemia Clinical Trial

Official title:
Cancer Stem Cells in Acute Leukemia

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT03735797
Other study ID # SH Can Stem
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date July 12, 2017
Est. completion date March 1, 2026

Study information
Verified date April 2024
Source Sanford Health
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Descriptive study of acute leukemia patients. Bone marrow aspirate or peripheral blood samples will be analyzed by next-generation sequencing for novel gene signatures and variations in transcriptional and epigenetic regulatory elements such as ARID5B and SALL4 variants.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 50
Est. completion date March 1, 2026
Est. primary completion date March 1, 2025
Accepts healthy volunteers No
Gender All
Age group 1 Month to 30 Years
Eligibility Inclusion Criteria: - Newly diagnosed or relapsed acute leukemia (AML or ALL) - Plan to undergo diagnostic bone marrow aspirate or peripheral blood if clinically indicated (i.e. WBC>50,000 and bone marrow contraindicated) - Age 1 month to 30 years - Understand and provide informed consent (subject if>18, legal guardian if<18) Exclusion Criteria: - Age 0 to 4 weeks - Treatment related leukemia or leukemia secondary to MDS - Situations that would limit compliance with study requirements or ability to willingly give consent

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Bone marrow aspirate or peripheral blood sample collection
Collection of specimen samples only

Locations
Country Name City State
United States Sanford Health Fargo North Dakota
United States Sanford Health Sioux Falls South Dakota

Sponsors (1)
Lead Sponsor Collaborator
Sanford Health

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary ARID5B polymorphism/mutation status Correlation of our experimentally validated Arid5b dependent transcriptional signature with primary patient samples measured by patient ARID5B expression and polymorphisms. 5 years
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